Study Comparing the Pharmacokinetics, Pharmacodynamics, a... | NCT01952548

Studies
Study Comparing the Pharmacokinetics, Pharmacodynamics, and Safety of K-312 in Healthy Adult Volunteers

NCT01952548

Sponsor

Kowa Research Institute, Inc.

Status

Completed

Last Update Posted

Dec 31, 2013Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

Safety and Tolerability

Interventions

K-312
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

May 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Not provided

First Submitted Date

Sep 19, 2013

First Submission Date that Met QC Criteria

Sep 25, 2013

First Posted Date

Sep 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2013

Last Update Posted Date

Dec 31, 2013Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Dose 1 Active	Experimental	Drug: K-312
Dose 2 Active	Experimental	Drug: K-312
Dose 3 Active	Experimental	Drug: K-312
Dose 4 Active	Experimental	Drug: K-312
Dose 5 Active	Experimental	Drug: K-312
Dose 6 Active	Experimental	Drug: K-312
Dose 7 Active	Experimental	Drug: K-312
Dose 1 Placebo	Placebo Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
K-312	Drug		Dose 1 Active Dose 2 Active Dose 3 Active Dose 4 Active Dose 5 Active Dose 6 Active Dose 7 Active

Measure	Description	Time Frame
Adverse Events		10 Days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject provides written informed consent before any study-specific evaluation is performed.
Subject is a healthy adult male or a female of non-childbearing potential between the ages of 18 and 45 years, inclusive.
Subject has a body mass index of 18.5 to 32 kg/m2, inclusive.

Exclusion Criteria:

Subject is a woman who is of childbearing potential or is breastfeeding.
Subject has the presence of an active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided